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The Effect of Inspiratory Muscle Training in People With Gastroesophageal Reflux Disease

ConditionGastro Esophageal Reflux
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of West Attica

About this trial

The present Randomized Control Trial will be a single centric, two arm parallel equivalence randomized controlled. Participants will be assigned to either the Inspiratory MuscleTraining (IMT) group (investigation) or to Sham IMT group (control). The assessment times were three (3) before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).

The measurements included: A. By measuring the Maximum Inspiratory Pressure (MIP) (Micro RPM) B. By measuring the Maximum Dynamic Inspiratory Pressure s-index (Powerbrethe K5)

The following instruments were included in the secondary outcome measures:

* Recurrent Gastroesophageal Reflux Disease Questionnaire (measurement of symptom frequency-RDQ Questionaire). * Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire (Quality of Life Measure-Reflux Qual short form questionnaire).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Inspiratory Muscle Traing

    Device

    IMT will be performed by applying resistance at 40% of the maximum inspiratory pressure (1 set of 30 repetitions 30 breaths per session). Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure.

  • Sham Inspiratory Muscle Training

    Device

    Inspiratory muscle training will be applied with a constant resistance load of 7cmH20

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Inspiratory Muscle TrainingExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal Inspiratory Pressure

Time frame
the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)

Secondary outcomes

1

Maximum Dynamic Inspiratory Pressure s-index

Time frame
the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)
2

Gastroesophageal Reflux Disease Questionnaire

Time frame
Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
3

Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire

Time frame
Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of West Attica

Lead sponsor

Source ClinicalTrials.gov
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